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Although patients and physicians have shown tremendous interest in the effect of diet on ulcerative colitis, there is a lack of significant evidence for providers to make practical recommendations with. In this study, the investigators hope to find out if dietary therapy by either the Specific Carbohydrate Diet (SCD) or the Mediterranean diet will help improve ulcerative colitis symptoms for patients with mild to moderately active disease. In addition, the investigators will compare disease activity and changes in the intestinal bacterial composition in the colon that occur with the Mediterranean or the SCD diet in active ulcerative colitis.
This study is proposed as a single-site randomized trial consisting of 10 study visits to Massachusetts General Hospital (MGH) over 12 weeks. Participants in this study will be randomly assigned to the SCD or Mediterranean diet. The investigators ask that participants exclusively consume their assigned diet for 6 weeks, with all meals and snacks prepared by the metabolic kitchen within MGH. Participants will need to pick up food from MGH every 5-7 days, and will meet with a study dietitian before they begin and weekly during the diet therapy.
There will be a screening visit to determine eligibility for the study, as well as study visits at weeks 0, 1, 2, 4, 6, and a 10 week follow-up at MGH, in which participants will fill out questionnaires. Participants will need to provide stool samples at screening, week 6, and week 10. In addition, blood will be drawn at week 0 and week 6, and if participants are getting a clinically-indicated colonoscopy at the time of screening, up to eight research biopsies may be collected during the procedure.
This randomized, parallel-group feeding study will examine the influence of Mediterranean and SCD diets on gut microbiota, luminal inflammation, and disease-specific clinical indices in patients with mild to moderate ulcerative colitis (UC). 50 patients will be randomized to follow either the SCD or Mediterranean diet in a 1:1 ratio. Once informed consent is obtained, subjects will enter a 2-week screening period. Eligible subjects will be enrolled in the feeding treatment for 6 weeks followed by an additional follow-up visit at 10 weeks (4 weeks after feeding treatment completion). The total time to complete the study is 12 weeks. The metabolic kitchen within the Metabolism and Nutrition Research Center at MGH Translational and Clinical Research (TCRC) Unit will be responsible for preparing and packaging food for participants to pick up, as well as performing all necessary nutritional assessments. Participants will be provided with 3 meals and 2 snacks a day during the 6-week dietary intervention. Patient menus will be identical in each diet and will rotate on a 3-day basis. Total calories for each diet will be tailored according to each participant's body composition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Specific Carbohydrate Diet | Experimental | Exclusive consumption of the specific carbohydrate diet for 6 weeks |
|
| Mediterranean Diet | Experimental | Exclusive consumption of the Mediterranean diet for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Specific Carbohydrate Diet | Other | Diet restricts all but simple carbohydrates and allows for inclusion of fresh fruits, vegetables, unprocessed meats, and homemade lactose-free cheese and yogurt. |
| Measure | Description | Time Frame |
|---|---|---|
| Partial Mayo Clinic Score | The partial Mayo clinic score measures disease activity, on a scale of 0 to 9. The higher scores indicate more severe disease activity (the worse outcome). | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Partial Mayo Clinic Score | The partial Mayo clinic score measures disease activity, on a scale of 0 to 9. The higher scores indicate more severe disease activity (the worse outcome). | Week 1, Week 2, Week 4, Week 10 follow-up |
| Inflammatory Bowel Disease Questionnaire (IBDQ10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hamed Khalili, MD, MPH | Contact | 978-882-6709 | hkhalili@partners.org | |
| Katherine Williams | Contact | 617-643-9374 | kwilliams81@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hamed Khalili, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24503132 | Background | Albenberg LG, Wu GD. Diet and the intestinal microbiome: associations, functions, and implications for health and disease. Gastroenterology. 2014 May;146(6):1564-72. doi: 10.1053/j.gastro.2014.01.058. Epub 2014 Feb 4. | |
| 8200562 | Background | Ferguson A, Sedgwick DM, Drummond J. Morbidity of juvenile onset inflammatory bowel disease: effects on education and employment in early adult life. Gut. 1994 May;35(5):665-8. doi: 10.1136/gut.35.5.665. |
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Only de-identified information may be shared with other collaborators and entities involved in generating data.
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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The investigators, subjects, and remaining study staff will not be intentionally unblinded. Due to the nature of the study, subjects, study staff, and investigators interacting with the subjects will likely be able to figure out what diet the subject is assigned to, however, the exact diet will not be explicitly revealed to them.
| Mediterranean Diet | Other | Diet rich in whole vegetables, fruit, plant-based protein, and olive oil, with moderate amounts of seafood and dairy, and limited in sugar-sweetened goods, red meat, and nutrients like heme and sodium. |
|
The IBDQ10 measures quality of life, on a scale of 10 to 70. The higher scores indicate a better outcome (better quality of life). |
| Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up |
| Short Form (12) Health Survey (SF-12) | The SF-12 measures health-related quality of life, split into physical and mental health scores on a scale of 0 to 100. The higher scores indicate a better outcome. | Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up |
| Simple Clinical Colitis Activity Index (SCCAI) | The SCCAI measures disease activity, on a scale of 0 to 21. The higher scores indicate a worse outcome (more severe disease activity). | Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up |
| stool microbiome | Stool samples will be taken at screening/baseline and week 6 and 10 to assess change in fecal microbiome pattern, measured using R2Aspread plating, QiagenAllPrep RNA/DNA Mini kit, and whole genome shotgun sequencing. | Week 6 and Week 10 follow-up |
| fecal calprotectin | Stool samples will be taken at screening/baseline and week 6 and 10 to assess change in fecal calprotectin levels. | Week 6 and Week 10 follow-up |
| C-reactive protein | Blood will be drawn at baseline and week 6 to assess change in C-reactive protein levels. | Week 6 |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |